A rapid reversed-phase liquid chromatography method for the determination of individual monoclonal antibody content in a co-formulated drug product.

Co-formulations of therapeutic monoclonal antibodies (mAbs) offer distinct advantages to the patient and clinic compared to single mAb drug products. However, the quantification of individual mAb content within a co-formulation is complicated as most mAbs exhibit similar physiochemical properties. While other techniques have been reported to fit this purpose, they fall short in terms of resolution, reproducibility and/or timescale, limiting their applicability. To address these shortcomings, a reversed-phase liquid chromatography (RPLC) method was developed, utilizing a diphenyl column packed with wide-pore superficially porous particles. Using the RPLC method, three mAbs in combined solutions were separated in under five minutes and subsequently quantified. Method qualification demonstrated precision, linearity and accuracy over a concentration range relevant to potential co-formulated drug products. The RPLC method is suitable for use during formulation development, quality control testing, and further applications for the analysis of individual mAb content within co-formulated mAb drug products.